(242 days)
No
The device description focuses on electro-mechanical components, sensors (pressure, temperature, ultrasonic), and basic control logic for pumps and alarms. There is no mention of AI, ML, or any data-driven learning or decision-making processes. The performance studies are bench tests and biocompatibility, not studies evaluating AI/ML performance metrics.
Yes.
The device controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures, which is a therapeutic intervention.
No
The device is described as a cardioplegia delivery system that controls, monitors, and delivers solutions during cardiopulmonary bypass procedures. Its functions (monitoring volume, flow rate, pressure, temperature) are related to the delivery and safety of the therapeutic solution, not to diagnosing a patient's medical condition. It's a therapeutic and monitoring device for a specific medical procedure.
No
The device description explicitly states it consists of an "electro-mechanical instrument" and "disposable Cardioplegia Sets," which are hardware components. The performance studies also include testing of these physical components.
Based on the provided information, the Medtronic CSS™ Cardioplegia Safety System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to control, monitor, and deliver solutions during cardiopulmonary bypass procedures, directly to the patient's myocardium. This is a therapeutic and monitoring function performed in vivo (within the living organism).
- Device Description: The description details a system for pumping, mixing, and monitoring fluids being delivered to the patient. It does not describe a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Anatomical Site: The anatomical site is the myocardium, which is a part of the living patient. IVDs typically interact with samples taken from the patient (e.g., blood, urine, tissue).
- Performance Studies: The performance studies described are bench tests and biocompatibility tests related to the device's function in delivering fluids and its interaction with blood and the body, not studies validating diagnostic performance on patient samples.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or compatibility testing. The Medtronic CSS™ Cardioplegia Safety System is a medical device used for direct patient treatment and monitoring during surgery.
N/A
Intended Use / Indications for Use
The Medtronic CSS™ Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures.
Product codes
DWB
Device Description
The Medtronic CSS Cardioplegia Safety System Model 990 consists of an electro-mechanical instrument and disposable Cardioplegia Sets. The instrument delivers cardioplegia solution to the patients myocardium through a system of dual peristaltic independently operated pumps. One pump is dedicated for the delivery of blood, and the other pump is dedicated for the delivery of crystalloid solution. The dual roller pumps feature interlocks so that the disposable tubing sets can only be loaded one way. Each roller pump is designed with a mechanically spring loaded back to maintain constant pressure on the tubing (ensures flow accuracy). The spring loaded feature also allows the mechanical release of fluid pressure in the case of over pressurization . The pump mechanism will not generate a line pressure greater than 1200 mmHg. To ensure patient safety, the microprocessor will shut the unit down if the line pressure or external pressure exceeds 500 mmHg. The user may also set the pressure limits at values less than 500 mmHg which will alarm, and shut the unit down. Each roller pump head is equipped with an air detection transducer which uses ultrasonic detection technology that will detect gross air (air bubble of at least 1/4" diameter) entering the inlet side of each roller pump. This feature is used to alert the user of an empty cardioplegia bag, low fluid or no fluid conditions entering the roller pump. The CSS Instrument monitors the volume of solution delivered. It provides two volume counters: one for volume delivered during individual phases of operation (resettable) and another for total volume delivered across all phases. A total volume limit can be set by the user, triggering an alert if exceeded. The instrument can control solution flow rate by direct adjustment (Manual mode) or by a user-defined constant pressure setting (Constant pressure mode), with a flow rate range of 0 - 990 ml/min. The ratio of blood to cardioplegia solution may vary (1:0, 1:1, 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, & 0:1, 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, 1:7, 1:8, 1:9). A Protocol mode allows customization and storage of up to 9 distinct cardioplegia protocols. The CSS Instrument monitors pressure at two sites: at the CSS Instrument line pressure and at the cannulae (external pressure). Separate alert and alarm levels can be set for each site. It also has two independent elapsed timers, typically used to monitor cross-clamp duration and cardioplegia delivery duration. The color central information display (CID) provides a constant indication of the instrument's operating state. Key-pad buttons adjacent to the display are used for setting adjustable parameters. The display shows running totals of solution volumes infused and provides both numeric and bar graph representation of pressure in mmHg or kPa. A configuration screen allows the user to select the language, pressure units, and alarm tone. Safety features include initial power on and continual run-time software tests. It has a two-stage alert-alarm process, presented visually and audibly. In an alarm condition, the unit automatically shuts off the roller pumps. Battery operation is automatically enabled upon AC power failure, offering 60 minutes of "On" time and 15 minutes of pumping time. The CSS can be mounted in most conventional heart-lung systems or on a 1.00" to 1.75" diameter horizontal pole, with an adapter for vertical pole mounting. The Graseby Medical Ltd., Model 3400 Anesthesia Syringe Pump 510(k) # K931318 can be connected to the CSS for administration of arresting agents. The Medtronic® CSS™ Cardioplegia Sets are single use, sterile and nonpyrogenic disposable devices designed to mix arterial blood from the cardiopulmonary bypass circuit with asanguineous cardioplegia solution at a variety of ratios. The set is available in four configurations: with CardioTherm™ Heat Exchanger and Standard patient line; with CardioTherm™ Heat Exchanger and Dual Lumen patient line; with Standard patient line No CardioTherm™ Heat Exchanger; and with Dual Lumen patient line No CardioTherm™ Heat Exchanger. The sets include medical grade silicone tubing and polycarbonate connectors for insertion into the roller pump head. The dual lumen patient line is tubing extruded with two separate lumens, one for cardioplegia delivery and the other for external pressure monitoring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
myocardium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified personnel during cardiopulmonary bypass procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In-Vitro Bench Testing:
In-vitro bench testing was performed to ensure the CSS Cardioplegia Safety System operated in accordance with Medtronic Bio-Medicus device specifications, and in accordance with applicable established standards to ensure user and patient safety. These tests included:
- The CSS™ Instrument Disposable Set Integrity Test
- Pump Flow Performance
- Blood Trauma Test
- Disposable Pressure Drop
- Occlusion and Maximum Pressure
- Constant Pressure Mode Performance
- Line Pressure Measurement System Performance
- External Pressure Measurement
- Gross Air Detection
- Disposable Chemical Resistance
- Temperature Monitoring
- Environmental Testing
- Battery Back-up
- Syringe Pump Performance Test
- Auxiliary Output and Overcurrent Protection
- ESD Testing
- EMI/EMC Immunity & Emissions Testing
- Dielectric and Chassis Leakage Test
Biocompatibility Testing:
The roller pump silicone tubing and polycarbonate connectors are the only components of the disposable set that are not currently marketed components in the CardioTherm™ Blood Cardioplegia Systems (K960755). These materials are however commonly used in the medical industry for various applications, including blood contact devices. These devices were tested in accordance with the FDA Blue Book Memorandum - #G95-1, and Biological Evaluation of Medical Devices Guidance - International Standard ISO 10993-1 "External Communicating Devices, Circulating Blood" - Contact Duration of A - limited ≤ 24 hours, and in accordance with United States Pharmacopoeia - XXIII. Based on the results of the biocompatibility testing performed, the materials used were determined to be biocompatible and nontoxic and, therefore, safe for their intended use.
Sterilization:
The CSS™ Cardioplegia Sets will be sterilized in accordance with a validated 100% (EtO) ethylene oxide sterilization method at a minimum sterility assurance level (SAL) of 10th The EtO sterilization process process qualifications and validation are in accordance with criteria described in the American National Standards Institute, Inc. (ANSI) standard ANSI/AAMI/ISO 11135-1994 (Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization).
EtO Residuals:
EtO dissipation curves have been developed and will apply to routine product release to assure that all products meet the limits for residual concentrations of ethylene oxide and ethylene chlorohydrin, and ethylene glycol as published in ANSI Standard Number ANSI/AAMI/ISO 10993-7:1995 (Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals).
Pyrogen Testing:
Routine Pvrogen Testing will be performed using the Limulus Amebocyte Lysate (LAL) method. Product testing and release criteria (less than .5 EU/ml) is in accordance to the December, 1987 Guidelines issued by the Food and Drug Administration, Office of Compliance ("Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices").
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sorin Biomedical Inc. - Sorin Blood Cardioplegia Console (K942582), Quest Medical Inc. - Myocardial Protection System (K953838), Sarns Inc/3M - Sarns 9000 Heart Lung Console (K871131), Medtronic, Inc. Cardiopulmonary - CardioTherm™ Blood Cardioplegia Delivery System (K960755)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4370 Roller-type cardiopulmonary bypass blood pump.
(a)
Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.(b)
Classification. Class II (performance standards).
0
K973237
SUMMARY OF SAFETY AND EFFECTIVENESS APR 27 1998
510(K) SUMMARY
COMPANY AND CONTACT PERSON
Medtronic Bio-Medicus, Inc. Cardiopulmonary Division 9600 West 76th Street Eden Prairie, MN 55344 tel. (612)944-7784 fax (612)944-7557
Thomas K. Johnsen Product Regulations Manager
TRADE NAME
Grand Cardioplegia Safety System Model 990.
COMMON, USUAL OR CLASSIFICATION NAME
The devices which comprise the CSS" Cardioplegia Safety System have been classified by the Cardiovascular Device Classification Panel as Class II devices.
21 CFR 870.4370 Roller type cardiopulmonary bypass blood pump
21 CFR 870,4240 Cardiopulmonary bypass heat exchanger
21 CFR 870.4390 Cardiopulmonary bypass pump tubing
NAME OF PREDICATE OR LEGALLY MARKETED DEVICE
Sorin Biomedical Inc. - Sorin Blood Cardioplegia Console (K942582) Quest Medical Inc. - Myocardial Protection System (K953838) Sarns Inc/3M - Sarns 9000 Heart Lung Console (K871131) Medtronic, Inc. Cardiopulmonary - CardioTherm™ Blood Cardioplegia Delivery System (K960755)
DESCRIPTION OF DEVICE
The Medtronic CSS Cardioplegia Safety System Model 990 consists of an electro-mechanical instrument and disposable Cardioplegia Sets. The details of these components are described below.
1
Instrument: CSS " Cardioplegia Safety System Model 990
Peristaltic Pumps:
The CSS " Instrument delivers cardioplegia solution to the patients myocardium through a system of dual peristaltic independently operated pumps. One pump is dedicated for the delivery of blood, and the other pump is dedicated for the delivery of crystalloid solution. The dual roller pumps feature interlocks so that the disposable tubing sets can only be loaded one way. Each roller pump is designed with a mechanically spring loaded back to maintain constant pressure on the tubing (ensures flow accuracy). The spring loaded feature also allows the mechanical release of fluid pressure in the case of over pressurization . The pump mechanism will not generate a line pressure greater than 1200 mmHg. To ensure patient safety, the microprocessor will shut the unit down if the line pressure or external pressure exceeds 500 mmHg. The user may also set the pressure limits at values less than 500 mmHg which will alarm, and shut the unit down. Each roller pump head is equipped with an air detection transducer which uses ultrasonic detection technology that will detect gross air (air bubble of at least 1/4" diameter) entering the inlet side of each roller pump. This feature is used to alert the user of an empty cardioplegia bag, low fluid or no fluid conditions entering the roller pump.
Volume:
Cardioplegia solution can be delivered to the patient at a controlled volume by selecting the relative pump speed for the ratio of blood to cardioplegia solution.
The CSS Instrument monitors the volume of solution delivered. During typical clinical procedures, cardioplegia is delivered in phases. Therefore, the CSS instrument provides two volume counters. The function of these counters is as follows:
-
- One volume counter reports the volume delivered during individual phases of operation. This counter can be reset to zero after each phase.
-
- The other volume counter records and reports the total volume delivered for all phases of operation.
A total volume limit can be set by the user. If the total volume limit is exceeded then an alert condition is triggered.
Flow Rate:
The CSS Instrument is able to control solution flow rate by flow and by pressure. Solution flow rate is controlled by direct adjustment of the flow control knob (Manual mode), or the CSS" can deliver solution by a user-defined constant pressure setting (Constant pressure mode). The flow rate can be adjusted from 0 - 990 ml/min.
2
Ratios:
Based on the patient's clinical need the ratio of blood to cardioplegia solution may vary (1:0, 1:1, 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, & 0:1, 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, 1:7, 1:8, 1:9). Alternative blood-to-cardioplegia ratios may be made available, as warranted by clinical need. A Protocol mode of operation allows the user to customize and store up to 9 distinct cardioplegia protocols; protocol settings can be changed as determined by the user needs.
Temperature Monitoring:
When monitoring temperature of the cardioplegia heat exchanger, use a Medtronic Probe, Model 1384 which contains a YSI 400 Thermistor. If monitoring of the myocardium is desired, a Medtronic Blood Management Myocardial Needle Temperature Probe must be used. Two myocardial needles are available. The 2100 series Myocardial Needle requires the #9012-147T adapter, and the 2400 series Myocardial Needle requires the #9004 adapter.
Pressure Monitoring:
The CSS " Instrument monitors pressure at two sites;
-
- at the CSS Instrument line pressure, and
-
- at the cannulae - external pressure
Separate alert and alarm levels can be setup by the user for each of these sites.
Gross Air Detector:
Each roller pump head is equipped with an air detection transducer which uses ultrasonic detection technology that will detect gross air (air bubble of at least 1/4" diameter) entering the inlet side of each roller pump. This feature is used to alert the user of an empty cardioplegia bag, low fluid or no fluid conditions entering the roller pump.
Timers:
The CSS Instrument is also equipped with two independent elapsed timers to assist the operator in the management of cardioplegia delivery. One timer is typically used to monitor cross-clamp duration, and one timer is typically used to monitor cardioplegia delivery duration. The timers can be reset at any time for use in other applications.
Central Information Display:
The color central information display (CID) provides a constant indication of the instrument's operating state. Key-pad buttons adjacent to the display are used for setting adjustable parameters. The display shows running totals of solution volumes infused and provides both numeric and bar graph representation of
3
pressure in mmHg or kPa. A configuration screen allows the user to select the language shown on the display, as well as the pressure measurement units, and the alarm tone.
Alarms and Alerts:
Safety features have been designed into the CSS " Instrument by initial power on and continual run-time software tests. The CSS Instrument has a two stage alert-alarm process. Alarms and alerts are presented both visually and audibly. If an alarm condition exists, the unit will automatically shut the roller pumps off until the alarm state is corrected.
Battery:
Battery operation, is automatically enabled in the case of AC power failure. This feature offers 60 minutes of "On" time (displays, and monitors), and 15 minutes of pumping time. The 15 minutes pumping time is the typical time of cardioplegia delivery during bypass surgery.
Hardware:
The CSS can be mounted in most conventional heart-lung systems, with the exception of heart-lung machines that require common air flow for the cooling of The CSS can also be mounted on a 1.00" to 1.75" diameter each module. horizontal pole. An adapter is provided for vertical pole mounting.
Instrument Accessory
The Graseby Medical Ltd., Model 3400 Anesthesia Syringe Pump 510(k) # K931318 can be connected to the CSS "Cardioplegia Safety System Model 990 by way of an RS232 port for administration of arresting agents (e.g. potassium).
Disposables
CSS" Cardioplegia Sets
The Medtronic® CSS" Cardioplegia Sets are designed to work specifically with the Medtronic® CSS" Cardioplegia Safety System, Model 990 instrument.
The CSS Cardioplegia Sets are single use, sterile and nonpyrogenic disposable devices designed to mix arterial blood from the cardiopulmonary bypass circuit with asanguineous cardioplegia solution at a variety of ratios, depending on clinical need. The CSS set is available in four configurations as follows:
4
-
- With CardioTherm™ Heat Exchanger and Standard patient line
-
- With CardioTherm™ Heat Exchanger and Dual Lumen patient line
- With Standard patient line No CardioTherm™ Heat Exchanger 3.
- With Dual Lumen patient line No CardioTherm™ Heat Exchanger 4.
The components used in the CSS" Cardioplegia Sets are identical to the components used in the currently marketed CardioTherm" Blood Cardioplegia Systems (K960755). There are only two modifications to the CardioTherm Blood Cardioplegia System tubing sets. These modifications are:
- silicone tubing set (with connectors) will be used as the pump header tubing, l) instead of polyvinyl chloride, and
- the patient line can be either dual or single lumen, instead of just single lumen. 2)
The CardioTherm" Blood Cardioplegia Systems are currently manufactured, packaged and sterilized by Medtronic Cardiopulmonary, Anaheim, CA. The CSS" Cardioplegia Sets will be manufactured, packaged and sterilized by Medtronic Cardiopulmonary, Anaheim, CA.
Silicone Tubing and Polycarbonate Connectors
Cardioplegia Set will include medical grade silicone tubing with Each CSS polycarbonate connectors to facilitate the insertion of the tubing into the roller Silicone tubing offers two distinctive advantages over polyvinyl pump head. chloride tubing when used in the roller pump. These advantages are:
-
- Less temperature sensitivity which offers more consistent and accurate flow (the pliability of polyvinyl chloride tubing tends to be affected by temperature change),
-
- Allows measurement of line pressure through the silicone tubing by means of the line pressure transducers mounted in the roller pump. This eliminates the need for additional in-line components.
The internal diameter of the CSS Cardioplegia Set silicone pump header tubing will not vary since the blood to solution ratios are controlled by the speed of the roller pumps.
Dual Lumen Patient Line
The dual lumen patient line is identical in material composition to the standard lumen patient line. The dual lumen patient line is tubing extruded with two separate lumens, one for the cardioplegia delivery, and the other for external pressure monitoring.
5
INTENDED USE OF THE DEVICE
The Medtronic CSS " Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures.
INTENDED USE OF PREDICATE/MARKETED DEVICES
Sorin Blood Cardioplegia Console ("BCC")
The Sorin Blood Cardioplegia Console ("BCC") is intended for use by qualified personnel during cardiopulmonary bypass procedures to control and monitor the introduction of blood and/or crystalloid in the management of cardioplegia.
Quest MPS Myocardial Protection System
The Quest MPS myocardial protection system is intended for use by perfusionists and surgeons trained in delivering cardioplegia solution to the myocardium during open heart surgery
Sarns 9000 Perfusion System
The Sarns 9000 Perfusion System is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. With Cardioplegia Control Module installed, the 9000 system is indicated to pump a set volume of cardioplegia fluid at a set pressure during cardiopulmonary bypass procedures.
Medtronic CardioTherm™ Blood Cardioplegia System (Disposable)
The Medtronic CardioTherm" Blood Cardioplegia System is intended for the mixing, cooling, warming and delivery of oxygenated blood and/or asanguineous cardioplegia solution.
SUBSTANTIAL EQUIVALENCE
The Medtronic CSS" Cardioplegia Safety System is substantially equivalent to other cardioplegia systems currently in commercial distribution. These predicate/marketed devices include:
Sorin Biomedical - (BCC) - Blood Cardioplegia Console (K942582) Quest Medical Inc. - (MPS) - Myocardial Protection System (K953838) Sarns/3M - Sarns 9000 Heart Lung Console (K871131) Medtronic, Inc. Cardiopulmonary - CardioTherm™ Blood Cardioplegia Delivery System (K960755) - Disposable component only ... _... ..
In determining substantial equivalence of the CSS" Cardioplegia Safety System, the decisionmaking process follows the 510(k) "Substantial Equivalence" flow diagram, and is presented as follows:
The CSS" Cardioplegia Safety System is being "compared to the following Marketed Devices":
6
- Sorin Biomedical (BCC) Blood Cardioplegia Console (K942582) .
- Quest Medical Inc. (MPS) Myocardial Protection System (K953838) .
- Sarns/3M Sarns 9000 Heart Lung Console (K871131) .
- CardioTherm™ Blood Cardioplegia Delivery System (K960755) .
The CSS" Cardioplegia Safety System has the "same indications statement and intended use" as the predicate/marketed devices
CSS™ Cardioplegia Safety System
The Medtronic CSS" Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures.
Sorin Blood Cardioplegia Console ("BCC")
The Sorin Blood Cardioplegia Console ("BCC") is intended for use by qualified personnel during cardiopulmonary bypass procedures to control and monitor the introduction of blood and/or crystalloid in the management of cardioplegia.
Ouest MPS Myocardial Protection System
The Quest MPS Myocardial Protection System is intended for use by perfusionists and surgeons trained in delivering cardioplegia solution to the myocardium during open heart surgerv
Sarns 9000 Cardioplegia Control Module
The Sarns 9000 Perfusion System is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
With Cardioplegia Control Module installed, the 9000 system is indicated to pump a set volume of cardioplegia fluid at a set pressure during cardiopulmonary bypass procedures.
CardioTherm™ Blood Cardioplegia System (Disposable)
The Medtronic CardioTherm Blood Cardioplegia System is intended for the mixing, cooling, warming and delivery of oxygenated blood and/or asanguineous cardioplegia solution.
The CSS" Cardioplegia Safety System has "new technological characteristics (e.g., design, materials and manufacturing processes)" from the predicate/marketed devices. Similar technological characteristics include;
- · pump cardioplegia solutions at specified flow rates by varying the speed of the pump
- · measure and display temperature (2)
- measure and display pressure (2) .
Additional technological characteristics are provided in the Designed Specification and Design Features Tables.
Like the Quest MPS Myocardial Protection System, the CSS" Cardioplegia Safety System allows the user to introduce arresting agents (e.g. potassium) into the cardioplegia circuit at specified
7
flow rates. The CSS" Cardioplegia Safety System does not offer a built in heater/cooler like the predicate/marketed devices, however, if heating and cooling of the cardioplegia solution is desired, an additional water line can be connected from the CardioTherm" heat exchanger to the heater/cooler used in the extracorporeal bypass circuit. This is a standard practice commonly used for this application.
These technological characteristics "could affect the safety and effectiveness of the device" However, these "new technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are accepted scientific methods which exist for assessing effects of these new technological characteristics".
"Performance data to assess the effects of these new technological characteristics" has been summarized below. These "performance data demonstrate" that the CSS" Cardioplegia Safety System is substantially equivalent to marketed devices.
SUMMARY OF TESTING PERFORMED
In-Vitro Bench Testing:
In-vitro bench testing was performed to ensure the CSS Cardioplegia Safety System operated in accordance with Medtronic Bio-Medicus device specifications, and in accordance with applicable established standards to ensure user and patient safety. These tests included:
- The CSS" Instrument Disposable Set Integrity Test .
- Pump Flow Performance .
- Blood Trauma Test .
- Disposable Pressure Drop .
- . Occlusion and Maximum Pressure
- Constant Pressure Mode Performance ●
- . Line Pressure Measurement System Performance
- External Pressure Measurement ●
- . Gross Air Detection
- . Disposable Chemical Resistance
- Temperature Monitoring ●
- . Environmental Testing
- Battery Back-up ●
- Syringe Pump Performance Test .
- Auxiliary Output and Overcurrent Protection .
- ESD Testing ●
- EMI/EMC Immunity & Emissions Testing ●
- . Dielectric and Chassis Leakage Test
Biocompatibility Testing:
The roller pump silicone tubing and polycarbonate connectors are the only components of the disposable set that are not currently marketed components in the CardioTherm" Blood Cardioplegia Systems (K960755). These materials are however commonly used in the medical industry for various applications, including blood contact devices. These devices were tested in
000016
8
accordance with the FDA Blue Book Memorandum - #G95-1, and Biological Evaluation of Medical Devices Guidance - International Standard ISO 10993-1 "External Communicating Devices, Circulating Blood" - Contact Duration of A - limited ≤ 24 hours, and in accordance with United States Pharmacopoeia - XXIII.
Based on the results of the biocompatibility testing performed, the materials used were determined to be biocompatible and nontoxic and, therefore, safe for their intended use.
Sterilization:
The CSS" Cardioplegia Sets will be sterilized in accordance with a validated 100% (EtO) ethylene oxide sterilization method at a minimum sterility assurance level (SAL) of 10th The EtO sterilization process process qualifications and validation are in accordance with criteria described in the American National Standards Institute, Inc. (ANSI) standard ANSI/AAMI/ISO 11135-1994 (Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization).
EtO Residuals:
EtO dissipation curves have been developed and will apply to routine product release to assure that all products meet the limits for residual concentrations of ethylene oxide and ethylene chlorohydrin, and ethylene glycol as published in ANSI Standard Number ANSI/AAMI/ISO 10993-7:1995 (Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals).
Pyrogen Testing:
Routine Pvrogen Testing will be performed using the Limulus Amebocyte Lysate (LAL) method. Product testing and release criteria (less than .5 EU/ml) is in accordance to the December, 1987 Guidelines issued by the Food and Drug Administration, Office of Compliance ("Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices").
CONCLUSION
Based on the information presented above, the CSS Cardioplegia Safety System demonstrates substantial equivalence to the predicate/marketed devices, and the CSS" Cardioplegia Safety System is safe for its intended use.
9
| SPECIFICATION |
|---|
| DESIGN |
| COMPARISON OF I |
| Feature | Medtronic CSS
The Medtronic CSST™ Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors and delivers oxygenated blood and/or asanguineous solutions during cardio-pulmonary bypass procedures. | Sorin BCC
The Sorin Blood Cardioplegia Console ("BCC") is intended for use by qualified personnel during cardiopulmonary bypass procedures to control and monitor the introduction of blood and/or crystalloid in the management of cardioplegia. | Quest MPS
The Quest MPS Myocardial Protection System is intended for use by perfusionists and surgeons trained in delivering cardioplegia solution to the myocardium during open heart surgery | Sarns 9000
With Cardioplegia control Module installed, the 9000 system is indicated to pump a set volume of cardioplegia fluid at a set pressure during cardio-pulmonary bypass procedures. |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | | | | |
| Power | 110/220 VAC 50-60 Hz | 115 VAC 60 Hz
94-128 VAC | 110/220 VAC 50-60 Hz | 115/220 VAC 50-60 Hz
103-126V |
| Power Accuracy | +/- 10% | | not available | |
| Pressure Range | 0-500 mmHg | 0-550 mmHg | 0-600 mmHg | -45 - 990 mmHg |
| Line Pressure Accuracy | line pressure 0-100 mmHg +/-10 mmHg
line pressure 101-500 mmHg +/-10% | +/- 5 mmHg | +/-2.5% or 3mmHg under all conditions | 6 L/min +/-.3 L/min |
| Flow Ratios (Blood:Crystalloid) | 0:1, 1:1, 2:1, .... 9:1 &
1:0, 1:1, 1:2, .... 1:9 | 0:1, 1:0, 1:1. 2:1, .... 16:1 | 0:1, 1:1, 2:1, .... 20:1 &
1:0, 1:1, 1:2, ... 1:9 | N/A |
| Temperature Range | 0-50°C | 0-40°C | 0-39°C | 0-49.9°C |
| Temperature Accuracy | +/-1°C | +/-1°C | +/-1°C | +/-.2°C |
| Timer Range | 0-99hr59min59sec | 0-99.9 ınin | N/A | cardioplegia timer range is 0-1 hour, auxiliary tiner range is 0 - 24 hours; clamp and puinp timer range is 0-10 hours |
| Timer Accuracy | 1 sec | .1 min | N/A | cardioplegia timer accuracy is +/- 1 min |
| Weight | 11 kg | 40 kg | 22 kg | unknown |
| Display | LCD | LCD | LCD | LCD and CRT |
| Splash Proof | Yes | Yes | Yes | Yes |
| UL | Yes, CUL | Yes | Unknown | Yes |
| CSA | Yes, CUL | Yes | Unknown | Yes |
| CE** | Yes | Uknown | Unknown | Unknown |
| Feature | Medtronic CSS | Sorin BCC | Quest MPS | Sarns 9000 |
| AC Power | Yes | Yes | Yes | Yes |
| AC Power Backup | Battery backup- fully functional
60 minutes of power-on time,
including 15 minutes of
pumping at typical operating
parameters; | Yes
Handcrank: device operates at
a reduced functionality while
on handcrank backup | No | Yes, battery backup and
handcrank |
| No. of Blood-Crystalloid Pumps | 2; 1 blood & 1 crystalloid pump | 2; 1 blood & 1 crystalloid pump | 2; 1 blood & 1 crystalloid pump | 1; blood/crystalloid pump |
| Type of Pump | Roller | Roller | Piston | Roller |
| Flow Units | mL/min | mL/min | mL/min | L/min or RPM |
| Flow Direction | one way, disposable can be
connected in only one way | both ways, depending on how
disposables are connected | one way, disposable can be
connected in only one way | both ways |
| Pulsatile Flow Control | No | No | No | Yes |
| Heater/Cooler | Separate and optional | Built-in | Built-in | Separate and optional |
| Temperature Sensor | Yes. 2 sensors | Yes. 2 sensors | Yes. 4 sensors | Yes, 3 sensors |
| Pressure Monitor | Yes, 1 internal sensor and 1
external delivery sensor | Yes. 2 sensors | Yes, 2 internal sensors and 1
external delivery sensor | Yes |
| Pressure Zeroing | Yes | Yes | Yes | Yes |
| Pressure Units | mmHg or kPa | mmHg or kPa | mmHg | mmHg or kPa |
| User Adjustable Pressure Limits | Yes | Yes | Yes | Yes |
| Pressure Alarm | Yes | Yes | Yes | Yes |
| Pressure Alert | Yes | No | Yes | Yes |
| Constant Pressure Mode | Yes | No | Yes | No |
| Volume Monitor | Yes | Yes | Yes | Yes |
| Volume Units | mL | mL | mL | cc |
| User Adjustable Volume Limit | Yes | No | Yes | No |
| Volume Alert/Alarm | Yes | No | Yes | No |
| Arresting Agent Delivery | Yes, optional | No | Yes, optional | No |
| Separate Monitor Screen | No, built-in | Yes | No, built-in | Yes |
| Gross Air Monitor | Yes | No | Yes | Yes |
| Gross Air Alarm/Alert | Yes | N/A | Yes | Yes |
| Specified disposable sets | Yes | No | Yes | No |
| Alarm Type | Audio and visual | Audio and visual | Audio and visual | Audio and visual |
| Timers | Yes, 2 | Yes, 2 | No | Yes, 4: 1 cardioplegia timer
1 pump timer, 1 clamp timer,
1 auxiliary timer |
- Based on customer input this accuracy is sufficient for this application
** Application will be filed before international release.
RESOLUTION WILL BE AT LEAST 300 DPI FOR ALL LINE ART AND HALFTONE INTERNATIONAL PERIODICALS
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COMPARISON DESIGN FEATURE
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Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird design, with three profiles facing right, suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 1998
Mr. Thomas K. Johnson Product Regulations Manager Medtronic Cardiac Surgery Medtronic Bio-Medicus, Inc. 9600 West 76th Street Eden Prairie, MN 55344
K973237 Re: CSS™ Cardioplegia Safety System Regulatory Class: II (Two) Product Code: DWB Dated: January 26, 1998 Received: January 27, 1998
Dear Mr. Johnson: : ・・・・
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Thomas K. Johnson
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callshan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
CSS™ Cardioplegia Safety System Device Name:
Indications For Use:
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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ું જ્યાર The Medtronic CSS™ Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated hlood and/or assanguineous cardioplegia solution during cardiopulmonary hypass procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | k 97 3237 |
| Prescription Use | X |
| (Per 21 CFR 801.109 | |
| OR Over-The-Counter-Use | |
| (Optional Format 1-2-96) |
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